Senior PV Officer

· Assures and exerts of activities leading to effective cooperation with clients in the area of ICSRManagement· Contributes to achieving company´s goals and objectives· Works independentlyClinical case processing SMEROLE AND RESPONSIBILITIES· Providing support to other activities undertaken by the project team on behalf of the client andthe company· Performing activities in the scope of ICSR management unit within agreed extent and timeframe(including, but not limited to): Processing Individual Case Safety Reports (ICSRs) from all sources in compliance withapplicable regulations, PrimeVigilance procedures and in accordance with client specificrequirements and timelines Performing ICSR follow up SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, SafetyManagement Plan review) Reconciliation (clinical, partners) Personal data protection Product Quality Complaint handling and interaction with Quality Assurance Medical Information interaction MedDRA and WHO coding Database Outputs and Reports (including data for monthly reporting to clients) Workflow & resource management· Mentoring and training of new and more junior employees within the department· Support of PV processes related to the ICSR management within PrimeVigilance and also toclients· Supporting ICSR SMEs or contributing as one of ICSR SMEs· More senior colleague may perform tasks assigned as per SOP to more junior position· Performing activities in the scope of ICSR management unit within agreed extent and timeframe· Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager